Last year, substantial changes to Medical Device Regulations (MDR) were approved by the European Council to take full effect in mid 2020. If you are planning to market a medical device there, it’s important to understand the new changes.

As a leading medical device design firm, Product Creation Studio adopted ISO 13485:2016 certification to underscore our commitment to continuous improvement and excellence in product development for the healthcare industry.

Maren Nelson, a PMP-certified, medical device consultant for Product Creation Studio talks to startups on how they can establish informal documentation from the start, examples of accepted criteria and three guiding principles of any quality management system.